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NDC 63629-1222-01 Dutasteride 0.5 mg/1 Details
Dutasteride 0.5 mg/1
Dutasteride is a ORAL CAPSULE, LIQUID FILLED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is DUTASTERIDE.
MedlinePlus Drug Summary
Dutasteride is used alone or with another medication (tamsulosin [Flomax]) to treat benign prostatic hyperplasia (BPH; enlargement of the prostate gland). Dutasteride is used to treat symptoms of BPH and may reduce the chance of developing acute urinary retention (sudden inability to urinate). Dutasteride may also decrease the chance that prostate surgery will be needed. Dutasteride is in a class of medications called 5-alpha reductase inhibitors. It works by blocking the production of a natural substance that enlarges the prostate.
Related Packages: 63629-1222-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dutasteride
Product Information
| NDC | 63629-1222 |
|---|---|
| Product ID | 63629-1222_fc112178-fac3-83f5-e053-6294a90aa17a |
| Associated GPIs | 56851020000120 |
| GCN Sequence Number | 051246 |
| GCN Sequence Number Description | dutasteride CAPSULE 0.5 MG ORAL |
| HIC3 | Q9B |
| HIC3 Description | BENIGN PROSTATIC HYPERTROPHY/MICTURITION AGENTS |
| GCN | 18428 |
| HICL Sequence Number | 024485 |
| HICL Sequence Number Description | DUTASTERIDE |
| Brand/Generic | Generic |
| Proprietary Name | Dutasteride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dutasteride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 0.5 |
| Active Ingredient Units | mg/1 |
| Substance Name | DUTASTERIDE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206574 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63629-1222-01 (63629122201)
| NDC Package Code | 63629-1222-1 |
|---|---|
| Billing NDC | 63629122201 |
| Package | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (63629-1222-1) |
| Marketing Start Date | 2016-11-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |